Compliance Key INC - Medical Device Training
William A. Levinson, P.E., is Keynote Speaker
at Compliance key Inc. He is the principal of Levinson Productivity
Systems, P.C. He is an ASQ Fellow, Certified Quality Engineer, Quality
Auditor, Quality Manager, Reliability Engineer, and Six Sigma Black
Belt. He is also the author of several books on quality, productivity,
and management, of which the most recent is The Expanded and Annotated
My Life and Work: Henry Ford's Universal Code for World-Class Success.
Overview
The
process capability index, and related process performance index,
reflect the ability of a manufacturing process to meet specifications. A
Six Sigma process has six process standard deviations between the
specification limits and the nominal.
The traditional process capability indices, however, rely on the assumption that the process follows a normal (bell curve) distribution. When this is not the case, special but off the shelf methods must be used to achieve accurate and meaningful results.
The traditional process capability indices, however, rely on the assumption that the process follows a normal (bell curve) distribution. When this is not the case, special but off the shelf methods must be used to achieve accurate and meaningful results.
Why should you attend this webinar?
Process
capability studies are basic quality management activities, and they
are often required by customers. They also go hand in hand with
deployment of statistical process control (SPC) charts. The generally
accepted practice relies on the textbook assumption that the process
follows the normal or bell curve distribution, which is far more common
in textbooks than in real factories. If the underlying distribution is
non-normal, the process performance index can be inaccurate by orders of
magnitude in terms of the nonconforming fraction (defects per million
opportunities, DPMO). In addition, the traditional SPC charts will not
function properly.
Meaningful
process performance indices and SPC charts can, however, be calculated
and deployed for non-normal distributions, and generally accepted off
the shelf methods are available.
Areas Covered in the Session:
- Know the difference between the process capability index, which reflects only short-term variation, and the process performance index, which reflects long-term variation, and also know how to calculate them.
- Know the relationship between the process performance index and the nonconforming fraction (defects per million opportunities), and the implication of a Six Sigma process.
- Understand the importance of the rational subgroup, or sample that reflects all variation sources in the process.
- Test process data for conformance to the normal distribution (or other selected distribution) to ensure that the process capability study is meaningful.
- Calculate meaningful process performance indices for non-normal data
Who can Benefit:
Manufacturing and quality professionals
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